Senior Post-Market Pharmacovigilance Specialist (Remote)

Location: Remote across multiple U.S. states

Company

Data-focused clinical research organization supporting pharmaceutical, biotech, and medical device companies with clinical trial data and regulatory submission expertise.

What you will do

• Lead global post-marketing case processing from intake through reporting and case closure.
• Develop and maintain pharmacovigilance workflows, procedures, and work instructions.
• Ensure compliance with Good Pharmacovigilance Practices, FDA requirements, ICH guidelines, and company SOPs.
• Process cases independently and lead the creation and updating of safety narratives and other deliverables.
• Lead client meetings, manage projects from start to finish, negotiate narrative development needs, and resolve issues.
• Identify process efficiencies and provide mentorship as a project lead and subject matter expert.

Requirements

• College degree in a scientific, medical, clinical, or related discipline, or equivalent relevant experience.
• At least 5 years of experience in drug safety, pharmacovigilance, or a similar field.
• Expertise with drug safety databases, MedDRA coding, and the WHO drug dictionary.
• Knowledge of ICH E2A, E2B(R3), E2D, GVP, FDA, GCP, and 21 CFR Part 11 requirements.
• Strong scientific knowledge, problem-solving, organizational, and communication skills.
• Proficiency with Microsoft Office applications.

Nice to have

• Master’s degree, PharmD, or PhD.
• Hands-on experience with clinical trials and pharmaceutical development.
• Familiarity with ISO 9001 and ISO 27001 standards.

Culture & Benefits

• Supportive, collaborative, and inclusive work environment.
• Opportunity to work with pharmaceutical, biotech, and medical device organizations.
• Global operating footprint across four continents.
• Recognized workplace culture and employee retention.